The objective of this study is to define the accuracy and the inter observer reliability of the clinical tests for assessing anterior cruciate ligament ruptures. These tests compose the standard in clinical testing for diagnosing or monitoring the…
ID
Source
Brief title
Condition
- Tendon, ligament and cartilage disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Sensitivity, specificity, likelihood ratios and predictive values of a positive
and negative test result are calculated for the following clinical tests: The
Lachman test, the pivot shift and the anterior drawer. All subjects already
underwent arthroscopic surgery which obtains the reference test.
Secondary outcome
Secondary this study assessed the intertester reliability and the value of the
medical history in the diagnostic process.
Background summary
Study results regarding the accuracy of clinical tests for assessing anterior
cruciate ligament ruptures gives us heterogeneous data. Reviewing the
literature, as in the meta-analysis of Benjaminse et al. (2006) shows the
shortcomings in methodological quality in most of the current data of these
studies. Especially the lack of using a valid control group and a valid
reference test is remarkable.
Study objective
The objective of this study is to define the accuracy and the inter observer
reliability of the clinical tests for assessing anterior cruciate ligament
ruptures. These tests compose the standard in clinical testing for diagnosing
or monitoring the traumatic knee.
Study design
Subjects in this study are asked to visit the out-patient clinic of the Erasmus
MC. A curtain will be used to screen the subject*s upper body and face from the
examiner*s view and to reduce the chance of recognition. The tests will be
administered by an orthopaedic surgeon and a general practitioner. Both will
fulfil the tests without any knowledge of the subject*s medical history. After
finishing these first tests, graded and noted the results, they are allowed to
read the subject*s standardized medical history. After this moment they will
re-test the subject with the same clinical tests. They are asked to decide
whether both test moments and the medical history match with a diagnosis of an
anterior cruciate ligament rupture.
Study burden and risks
Estimated burden for participating in the clinical tests and the KT-100
arthrometer test is approximately 1 hour. Regarding the inclusion and exclusion
criteria there is no additional risk in participating in this study.
Postbus 2040
3000 CA Rotterdam
NL
Postbus 2040
3000 CA Rotterdam
NL
Listed location countries
Age
Inclusion criteria
Visit of outpatient clinic because of tarumatic knee complaints and arthroscopy in the period January 2008 till March 2010.
Minimal age of 18 year.
- free range of motion, no effusion and no knee pain which will influence the physical examination.
-Contralateral knee with a free history.
Exclusion criteria
-Presence of hydrops/ haemarthros in one of both knees, which will influence the termination of physical examination
-An extension deficit of minimally 10° in one of both knees;
-A maximal flexion of 100° or less in one of both knees;
-A history of fracture of the tibia or femur;
-A anterior cruciate ligament reconstruction;
-Knee pain of one of both knees which will influence the termination of physical examination
-A not traumatic rupture of the anterior cruciate ligament rupture
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL31949.078.10 |